Exercise and Pioglitazone for HIV-Metabolic Syndromes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin Yarasheski, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00639457
First received: March 18, 2008
Last updated: September 16, 2013
Last verified: September 2013
Results First Received: May 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Type 2 Diabetes
Obesity
HIV
AIDS
Cardiovascular Disease
Lipodystrophy
Interventions: Drug: Pioglitazone
Behavioral: Exercise training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
HIV-infected men and women (18 – 60 yr old) were recruited from the AIDS Clinical Trials Unit, the Infectious Diseases Clinic, and the Volunteers for Health Program at Washington University School of Medicine, St. Louis MO between Jan 2005-Dec 2010. Participants were randomly assigned (1:1) to 4 mo of pioglitazone with or without exercise training.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion: AIDS diagnosis, non-compliant with anti-HIV medications, unstable CD4+ T-cell count or plasma HIV viremia, illegal drug abuse.

Reporting Groups
  Description
Pioglitazone Pioglitazone (Actos; 30mg/day) for 16 weeks.
Pioglitazone + Exercise Training Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.

Participant Flow:   Overall Study
    Pioglitazone     Pioglitazone + Exercise Training  
STARTED     22     22  
COMPLETED     20     19  
NOT COMPLETED     2     3  
Withdrawal by Subject                 2                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pioglitazone Pioglitazone (Actos; 30mg/day) for 16 weeks.
Pioglitazone + Exercise Training Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
Total Total of all reporting groups

Baseline Measures
    Pioglitazone     Pioglitazone + Exercise Training     Total  
Number of Participants  
[units: participants]
  22     22     44  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     22     44  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 2     46  ± 2     45  ± 2  
Gender  
[units: participants]
     
Female     3     2     5  
Male     19     20     39  
Region of Enrollment  
[units: participants]
     
United States     22     22     44  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insulin-stimulated Glucose Disposal Rate   [ Time Frame: Baseline and week16 ]

2.  Secondary:   Visceral Fat Volume   [ Time Frame: Baseline and week 16 ]

3.  Secondary:   Abdominal Subcutaneous Fat Volume   [ Time Frame: Baseline and week 16 ]

4.  Secondary:   Hepatic Lipid Content   [ Time Frame: Baseline and week 16 ]

5.  Secondary:   Hepatic Glucose Production Rate   [ Time Frame: Baseline and week 16 ]

6.  Secondary:   Serum Lipid and Lipoprotein Levels   [ Time Frame: Baseline and week 16 ]

7.  Secondary:   Liver Enzyme Levels   [ Time Frame: Baseline and week 16 ]

8.  Secondary:   Hemoglobin   [ Time Frame: Baseline and Week 16 ]

9.  Secondary:   Hematocrit   [ Time Frame: Baseline and Week 16 ]

10.  Secondary:   Serum Adiponectin Levels   [ Time Frame: Baseline and week 16 ]

11.  Secondary:   Myocardial Contractility   [ Time Frame: Baseline and week 16 ]

12.  Secondary:   Myocardial Contractility-LV Ejection Time   [ Time Frame: Baseline and week 16 ]

13.  Secondary:   Myocardial Contractility-DT   [ Time Frame: Baseline and week 16 ]

14.  Secondary:   Myocardial Contractility-SBP   [ Time Frame: Baseline and week 16 ]

15.  Secondary:   Myocardial Contractility-DBP   [ Time Frame: Baseline and week 16 ]
  Hide Outcome Measure 15

Measure Type Secondary
Measure Title Myocardial Contractility-DBP
Measure Description Diastolic blood pressure; vascular pressure during ventricular relaxation (diastole)
Time Frame Baseline and week 16  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.

Reporting Groups
  Description
Pioglitazone Pioglitazone (Actos; 30mg/day) for 16 weeks.
Pioglitazone + Exercise Training Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.

Measured Values
    Pioglitazone     Pioglitazone + Exercise Training  
Number of Participants Analyzed  
[units: participants]
  11     10  
Myocardial Contractility-DBP  
[units: mmHg]
Mean ± Standard Error
   
Baseline DBP     65  ± 3     68  ± 5  
Week 16 DBP     67  ± 4     61  ± 4  

No statistical analysis provided for Myocardial Contractility-DBP




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No intervention and exercise training only control groups were not included. Intracellular mechanisms were not explored. Relatively small number of participants taking a variety of anti-HIV medication regimens.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kevin Yarasheski, PhD
Organization: Washington Univ Med Sch
phone: 3143628173
e-mail: key@wustl.edu


Publications of Results:
Reeds DN, Cade WT, Mondy K, Bopp C, Lassa-Claxton S, Yarasheski KE. Pioglitazone ± exercise training reduces liver lipid content and improves insulin sensitivity in HIV with impaired glucose tolerance (IGT). Antivir Ther. 12 Suppl 2: L14, 2007.


Responsible Party: Kevin Yarasheski, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00639457     History of Changes
Other Study ID Numbers: DK 049393 (completed), WU 157
Study First Received: March 18, 2008
Results First Received: May 2, 2013
Last Updated: September 16, 2013
Health Authority: United States: Federal Government